Indigo Diabetes Announces First Participant Enrolled in the SHINE Clinical Trial
BELGIUM – Ghent, September 29, 2022 – Indigo Diabetes N.V. (‘Indigo’ or the ‘Company’), a pioneering developer of medical options utilizing nanophotonics, at this time pronounces the enrollment of the first participant in Belgium in the SHINE medical trial, which is designed to guage the longer-term stability of Indigo’s steady multi-metabolite (‘CMM’) machine.
Indigo’s subcutaneously inserted CMM machine is in growth for the steady measurement of glucose, ketone and lactate ranges in individuals residing with diabetes.
This first participant enrollment, an necessary Company milestone, has taken place at Antwerp University Hospital (UZA) and represents the first of 15 individuals to be recruited in the trial throughout Belgium, France and Slovenia.
Indigo has not too long ago submitted a paper on the knowledge from its efficiently concluded GLOW trial, the first-in-human medical research of Indigo’s CMM sensor, to a peer-reviewed journal for publication.
Professor Christophe De Block, Principal Investigator of the SHINE trial at Antwerp University Hospital commented: “Continuous monitoring of glucose levels is key in managing diabetes to prevent devastating acute and long-term complications. The possibility of monitoring other biomarkers such as ketones and lactate will take continuous monitoring to the next level. It is a privilege to lead the SHINE clinical trial to evaluate the safety and performance of this ground-breaking novel technology.”
Dr. Danaë Delbeke, CEO, Inventor, and Co-founder of Indigo Diabetes, added: “The start of the SHINE trial is an important milestone for Indigo and follows the successful conclusion of the GLOW trial earlier this year, the results of which we’ve submitted to a peer-reviewed journal for publication. Many multi-metabolite monitoring devices under development sit on the skin and are highly visible, which some people do not like because they can feel self-conscious, stigmatized and uncomfortable. Indigo’s continuous multi-metabolite monitor is subcutaneously inserted and is designed to be inconspicuous. We look forward to seeing how it performs in this longer-term stability trial.”
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About Indigo Diabetes N.V.
Indigo Diabetes N.V. (Indigo) is a pioneering developer of medical options using nanophotonics. Indigo was based by Danaë Delbeke and her staff in 2016. Today Indigo is creating the world’s first invisible sensor for individuals residing with diabetes to handle their want for steady correct glucose and ketone monitoring with an improved consumer expertise. Indigo exploits groundbreaking photonics know-how accountable for revolutionizing the Internet to rework diabetes administration. Indigo relies in Ghent, Belgium. Find out extra at www.indigomed.com.
About Indigo Diabetes’s CMM sensor
Indigo Diabetes’s CMM sensor is a small spectrometer-on a-chip to watch in-vivo concurrently and repeatedly a number of metabolites. The inert, miniature built-in silicon photonics spectrometer chip measures the absorption of sunshine in the interstitial fluid to quantify the focus of a number of metabolites concurrently with out the use of enzymes or fluorophores. Once inserted beneath the pores and skin the CMM sensor is invisible to the bare eye and can join securely and wirelessly to cellular gadgets to indicate and seize the focus profiles of the metabolites for the consumer. A chargeable sensor battery powers the measurements. It is anticipated that the sensor can have a lifetime as much as 2 years. Preclinical research have efficiently demonstrated proof of idea with promising accuracy.
Further particulars on the SHINE Study
SHINE is an open label, interventional, multicentre, potential feasibility research, designed to guage the security of the implantation and preliminary efficiency of the SHINE SYSTEM. The machine will probably be inserted for six months, with the general research anticipated to final 12 months from the first participant, first go to (FPFV) to the final participant, final go to (LPLV.)
Up to fifteen research individuals with diabetes mellitus will probably be recruited throughout the following websites: University Medical Centre Ljubljana in Slovenia, Antwerp University Hospital in Belgium, and Lapeyronie Montpellier University Hospital in France.
All topics will take part in 8 measurement visits over the 6 months of the research period. During these visits knowledge will probably be collected on the spectra of glucose, ketones and lactate and in contrast with the values of metabolites analysed instantly from topic’s blood. Glucose ranges may even be monitored by CGM machine Dexcom G6.
Further particulars on the GLOW Study
GLOW, listed on www.clinicaltrials.gov beneath the identifier NCT04782934, was designed to guage the security of the sensor and the short-term integration into the tissue and was a potential, single-center early feasibility research performed at Antwerp University Hospital, Belgium. Data was additionally collected from the seven research individuals (three wholesome topics, and 4 topics with sort 1 diabetes) and used to develop the machine to permit real-time, steady measurement of key metabolite ranges in adults with diabetes.
Participants receiving the CMM sensor had the sensor inserted as much as 10 mm deep in the subcutaneous stomach tissue utilizing native anaesthetic. The sensor remained in situ for 30 days after which it was eliminated. Each participant had 6 measurement visits over the 30-day trial interval, throughout which knowledge for glucose, lactate and ketone ranges was collected and in comparison with relevant requirements beneath managed circumstances (hypo/hyperglycaemia, anaerobic train, ketogenic circumstances and through administration of potential interferents comparable to NSAIDS, vitamin C).
Contacts
Indigo Diabetes N.V.
Dr Danaë Delbeke, CEO
Email: [email protected]
Communications
Consilium Strategic Communications
Ashley Tapp, Alexandra Harrison
Tel: +44 (0)20 3709 5700
Email: [email protected]
